Phase 2
Completed N=365
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT02765490 ↗
Enrolled (actual)
365
Serious AEs
3.0%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) — 98.9; 97.8 Percentage of Participants
Summary
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) |
98.9; 97.8 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24) |
98.9; 97.3 | — |
| SECONDARY Number of Participants With Viral Relapse |
1; 4 | — |
| SECONDARY Number of Participants With Late Viral Relapse |
0; 1 | — |
| SECONDARY Percentage of Participants With On-treatment Failure |
0; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT) |
99.5; 98.4 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection
- Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
- Absence of cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or sexually active male
Exclusion Criteria
- Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
- Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free
- Current or prior history of clinical hepatic decompensation
- History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or a nursing female
Data sourced from ClinicalTrials.gov (NCT02765490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.